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458 device results listed.

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Diagnostic Kit for Cardiac Troponin I

Diagnostic Kit for Cardiac Troponin I Test Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315731
Basic UDI-DI: B-04260163315731
Reference: 07CTN15025
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:39

Manufacturer products View details

Diagnostic Kit for CK-MB

Diagnostic Kit for CK-MB

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: MP Biomedicals Germany GmbH
Manufacturer SRN: DE-MF-000020991
UDI-DI: 04260163315717
Basic UDI-DI: B-04260163315717
Reference: 07CKMB5025
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:39

Manufacturer products View details

Cardiac Troponin T Rapid Test Device – WB/S/P

Cardiac Troponin T Rapid Test Device – WB/S/P

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: D-D-CTTD1099
Basic UDI-DI: B-D-CTTD1099
Reference: D-CTTD10
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Spain
Authorised representative: Advena Limited
Last updated: 04.08.2026 19:30

Manufacturer products Authorised representative products Authorised representative actors View details

High-Sensitivity NT-proBNP Test Cassette

High-Sensitivity NT-proBNP Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-SNBNP-402G9
Basic UDI-DI: B-ACO-SNBNP-402G9
Reference: ACO-SNBNP-402
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Lithuania
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

High-Sensitivity Cardiac Troponin T Test Cassette

High-Sensitivity Cardiac Troponin T Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-SCTT-4027P
Basic UDI-DI: B-ACO-SCTT-4027P
Reference: ACO-SCTT-402
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Finland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Markers Combo Test Cassette

Cardiac Markers Combo Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-CMC-475K3
Basic UDI-DI: B-ACO-CMC-475K3
Reference: ACO-CMC-475
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

CA125 Test Cassette

CA125 Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-CA125-402YF
Basic UDI-DI: B-ACO-CA125-402YF
Reference: ACO-SCTT-402
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Greece
Authorised representative: VidaQuick Biotech S.L.
Last updated: 04.08.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

R23-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571823008
Basic UDI-DI: B-06941571823008
Reference: R23-112
EMDN: W0102160702
EMDN description: MYOGLOBIN - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

R22-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571822001
Basic UDI-DI: B-06941571822001
Reference: R22-112
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

R189-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571818905
Basic UDI-DI: B-06941571818905
Reference: R189-112
EMDN: W0102160799
EMDN description: CARDIAC MARKERS - RT & POC - OTHER
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

R183-116

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571818301
Basic UDI-DI: B-06941571818301
Reference: R183-116
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

R180-116

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571818097
Basic UDI-DI: B-06941571818097
Reference: R180-116
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin/CK-MB/Troponin I Combo Rapid Test Cassette

Myoglobin/CK-MB/Troponin I Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983188715
Basic UDI-DI: B-06936983188715
Reference: CMA-435
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

Heart-type fatty acid-binding protein Reagent Kit

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009411
Basic UDI-DI: B-06934175009411
Reference: 12600548
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin T Quantitative Test

5J09C1

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963717085
Basic UDI-DI: B-06921963717085
Reference: 5J09C1
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:59

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I Quantitative Test

5J02C1

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963717078
Basic UDI-DI: B-06921963717078
Reference: 5J02C1
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:59

Manufacturer products Authorised representative products Authorised representative actors View details

NT-proBNP Quantitative Test

5J07C2

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963717054
Basic UDI-DI: B-06921963717054
Reference: 5J07C2
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:59

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid CK-MB Test Card

1J01C2

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963716972
Basic UDI-DI: B-06921963716972
Reference: 1J01C2
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:59

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid NT-proBNP Test Card

1J07C2

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963716989
Basic UDI-DI: B-06921963716989
Reference: 1J07C2
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:59

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Myoglobin Test Card

1J03C2

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963716965
Basic UDI-DI: B-06921963716965
Reference: 1J03C2
EMDN: W0102160702
EMDN description: MYOGLOBIN - RT & POC
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details